SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO— 510(k) K123304

Name: FDA 510(k) clearance K123304
Creator: U.S. Food and Drug Administration
Published: 2013-01-24

Substantially Equivalent

Ivoclar Vivadent, AG

FDA 510(k) clearance K123304 for SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO, Substantially Equivalent on 2013-01-24. Applicant: Ivoclar Vivadent, AG. Device class: 2.

Clearance details

Applicant: Ivoclar Vivadent, AG
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2012-10-24
Decision date: 2013-01-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Amherst, NY, US

Download summary PDF View on FDA.gov ↗

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